Elaprase (idursulfase) is a medication that can be used to improve walking ability and lower spleen size in people with Hunter syndrome. It's only given once weekly as an intravenous (IV) infusion by a healthcare provider. But infusions typically take 1 to 3 hours and can put you at risk for serious allergic reactions. It's only available as a brand name medication, so it can be expensive.
Improve walking ability in people ages 5 years and older with Hunter syndrome
Lower spleen size in people ages 16 months to 5 years old with Hunter syndrome
Elaprase (idursulfase) is an enzyme replacement therapy (ERT), which means that it replaces an enzyme (protein) in your body. If you have Hunter syndrome, you either don't have any or don’t have enough of an enzyme that breaks down certain sugars in your body. These sugars build up in your body over time and can cause symptoms such as stiff joints, lung problems, and heart problems. Elaprase (idursulfase) replaces the missing enzyme and breaks down the sugars, providing relief from some symptoms of Hunter syndrome.
Source:Â DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Bone or muscle pain
chills
fast, pounding, or irregular heartbeat or pulse
feeling of warmth
headache
hives or welts
rash
redness of the face, neck, arms, and occasionally, upper chest
redness of the skin
tightness in the chest
unusual tiredness or weakness
Less common
Blurred vision
confusion
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
sweating
Incidence not known
Difficulty with swallowing
dilated neck veins
extreme fatigue
heart stops
irregular breathing
no breathing
no pulse or blood pressure
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
unconscious
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Taken once a week
The only FDA-approved ERT for people with Hunter syndrome
Can be used in children as young as 5 years old to help them walk longer distances
If it's well-tolerated, you might be able to get at-home infusions and shortened infusion times
Can cause a life-threatening allergic reaction
Can worsen lung and heart problems
Must be given by a healthcare provider, usually at a treatment center
Only available as a brand medication, so it can be expensive
Mark your calendar to help you remember your weekly infusion appointments so you don't miss any doses of Elaprase (idursulfase).
Life-threatening allergic reactions can occur up to 24 hours after treatment with Elaprase (idursulfase). Tell your provider right away if any signs of an allergic reaction happen during or after your infusion. Those signs can include trouble breathing, dizziness, rash, hives, itching, flushing, fever and/or headache.
Let your provider know if you’ve had an allergic reaction to Elaprase (idursulfase). You might have to take medications such as, antihistamines, corticosteroids, or rescue inhalers to help prevent or ease an allergic reaction before or during your next treatment. Or, you might need to get the infusion over a longer period of time. Your provider can decide whether or not it's safe to continue with treatments after a serious allergic reaction.
Elaprase (idursulfase) probably won't improve your child's ability to walk right away (for children 5 years and older). It can take some time, maybe even up to a year, for you to see noticeable improvements. Talk with your child's provider if you have questions about whether or not this medication is working.
If you or your child takes Elaprase (idursulfase), talk to your provider about participating in the Hunter Outcome Survey. This program helps track how Hunter syndrome progresses, and the long-term effects Elaprase (idursulfase) might have on the people who take it.
Elaprase (idursulfase) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: People ages 7 years and younger who have certain types of genetic mutations (damage)
Get medical attention right away if you experience symptoms such as trouble breathing, swelling of the face, throat or tongue, wheezing, hives, rash, flushing, or vomiting. Elaprase (idursulfase) can cause serious allergic reactions during and up to 24 hours after the IV infusion. Rarely, these reactions can even happen after you’ve safely received Elaprase (idursulfase) infusions in the past. If you ever had any prior allergic reaction to Elaprase (idursulfase), let your provider know so that they can give you treatments, such as inhalers, corticosteroids, and antihistamines during or after future Elaprase (idursulfase) infusions.
Some people can develop antibodies, proteins that attack unfamiliar chemicals in the body, against Elaprase (idursulfase). This means that the medication won't work as well, because your body thinks it's a harmful substance and attacks it. This is most likely to occur in people with certain genetic mutations. Talk with your provider if you think this medication isn’t working for you.
Risk factors: Lung infection | Breathing problems
Elaprase (idursulfase) can cause an allergic reaction that lowers your ability to breath. If you have breathing problems or an infection in your lungs, you're more at risk for not being able to recover from a severe allergic reaction that affects your breathing. This can lead to serious problems such as seizures or passing out. Your provider might suggest rescheduling your dose if you're experiencing short-term breathing problems due to an infection.
Risk factors: Too much fluid
Elaprase (idursulfase) can make heart problems worse, especially if you're already at risk of having too much fluid in your body. If you have heart problems, you might need to be observed by your provider for a longer period of time after your infusion to make sure you don't have any serious side effects from it.
Elaprase (idursulfase) is only available as an IV infusion that’s given by a healthcare provider. The dose of this medication depends on your weight.
In general, the dosing of Elaprase (idursulfase) is 0.5 mg/kg given weekly as an IV infusion.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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